Fentanyl 1000mcg/100mL — Class III drug recall D-0480-2024
Completed recall by Hikma Injectables USA Inc, reported 2024-05-08, distributed nationwide. Labeling: Wrong Barcode
| Recall number | D-0480-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hikma Injectables USA Inc, Dayton, NJ, United States |
| Recall initiated | 2024-04-30 |
| Classified | 2024-05-02 |
| Reported by FDA | 2024-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 1,895 bags |
| Reason classes | labeling |
| NDC | 63037-0100-05 |
| Lot numbers | CH0324001 |
| Expiration dates | 2025-03-04 |
Product
Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05
Reason for recall
Labeling: Wrong Barcode
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0480-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.